Titan Medical Inc (TMDIF)

[renovatio33]

Yep, the human confirmatory studies were initially not considered to be a requirement, but at the end of last year, they did indeed confirm with the FDA that those tests would be required, and as such, they moved design freeze further out to better align.

So keep in mind, ALL platforms under development, who intend to seek FDA approval, will be subject to the same requirements. Likely why Medtronic also delayed, to some extent.

All of this info was available in their filings. And there has been patent activity to address the port.

Just have to continue to do your DD.